FDA Registration
Active
🇺🇸 United States
Optum Distribution Center, LLC
Reg #: 3009456923
·
FEI: 3009456923
·
Expires 2026
Products
11
Proprietary Names
1
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- Optum Distribution Center, LLC
- Registration Number
- 3009456923
- FEI Number
- 3009456923
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 877 Franklin Rd, # 205
- City
- Marietta
- State
- GA
- ZIP
- 30067
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113159
Owner / Operator
- Firm Name
- UnitedHealth Group
- Operator Number
- 10045256
- Address
- 1 Health Drive, MN103-0400
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2015-05-15 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-08-30 |
| Intravenous Extension Tubing Set | OJA | Class 2 | General Hospital | No | 2026-03-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-11-04 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2023-08-30 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2023-08-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2020-11-04 |
| Pump, Infusion, Pca | MEA | Class 2 | General Hospital | No | 2020-11-04 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2020-11-04 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2024-04-10 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2023-08-30 |
Proprietary Names
Bluetooth Dual Mode Body Scale
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)